Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis

NCT01919827 | Completed Phase 1 DMC

• 1 other identifier: CMM/FPI
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

Clinical Trial Phase I, open, multicentric, non randomized, study with escalating doses, to evaluate the safety and feasibility of treatment with mesenchymal stem cells in patients with diagnosis of idiopathic pulmonary fibrosis. Primary endpoint: The aim is to evaluate the safety and feasibility of the endobronchial administration of mesenchymal autolog stem cells derived from bone marrow (BM-MSC)in patients with mild-to-moderate idiopathic pulmonary fibrosis. Secondary endpoint:Assess the possible effect of the infusion of BM-MSC in stopping the fall of pulmonary function in patients with mild-to-moderate idiopathic pulmonary fibrosis.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis; Stem cells; Mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse side effects.

  Number of participants with adverse side effects, and according to the level of severity: 1. Low level: Increase in cough, fever or skin reactions 2. Medium level: Infections not requiring hospital admission, mild alterations of renal or liver function 3. High level: Death or major side effects requiring hospitalization: 1. Worsening dyspnea with \>=10% reduction in forced vital capacity, reduction in arterial pressure oxygen \>= 10 mmHg and radiology progression between 3 months separated visits. 2. Need for hospitalization due to respiratory failure requiring mechanical ventilation, worsening in gases exchange or lung infection. 3. Carcinogenesis at 12 months after the endobronchial infusion of mesenchymal stem cells.

  Up to 12 months

Secondary Outcomes (1)

• Efficacy of the infusion of mesenchymal stem cells in stopping the fall in pulmonary function in patients with mild to moderate IPF

  Up to 12 months

Study Arms (1)

MSC endobronchial infusion

EXPERIMENTAL

Biological: Endobronchial infusion of adult mesenchymal stem cells; Biological: Autologous mesenchymal stem cells derived from bone marrow

Interventions

Endobronchial infusion of adult mesenchymal stem cells BIOLOGICAL

MSC endobronchial infusion

Autologous mesenchymal stem cells derived from bone marrow BIOLOGICAL

MSC endobronchial infusion

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capacity for signing informing consent and express the willing to fulfill all the requirements of the study protocol during the study.
• The patients should be, in the researcher opinion, capable to fulfill all the requirements of the trial.
• Male or female patients, 30 to 80 years old, inclusive.
• Diagnosis of idiopathic pulmonary fibrosis according to the following criteria, based on the ATS/ERS Guidelines:
• Definite or probable usual interstitial pneumonia confirmed by surgical lung biopsy.
• In the absence of surgical lung biopsy, all the following:
• i. High resolution CT (HRCT) showing definite findings for idiopathic pulmonary fibrosis (FPI): bibasal reticular opacities with minimal ground glass opacities.
• ii. Absence of other known causes of FPI including toxicity from drugs, environmental exposure or connective tissue diseases.
• iii. Pulmonary function tests showing ventilatory restrictive pattern and/or impaired gas exchange (FVC and/or DLCO \<90% of predicted)
• FVC ≥ 50% of predicted value with ratio of FEV1 to FVC ≥ 0.70.
• DLco (corrected for hemoglobin) ≥ 35% predicted value.

You may not qualify if:

• Any of the following:
• Current pregnancy or lactation.
• Findings that are diagnostic of an interstitial pneumonia or restrictive respiratory disease condition other than UIP.
• Obstructive pulmonary disease defined by FEV1/FVC \< 0,7 or significant emphysema on HRCT.
• Chronic cardiac failure (functional class NYHA III/IV) or left ventricular ejection fraction \< 25%.
• The patient requires hemodialysis, peritoneal dialysis or hemofiltration.
• History of malignancy, with the exception of skin squamous or basocellular carcinoma or cervix in situ carcinoma treated successfully.
• The patient is participating in a clinical trial which includes other drugs or research products within the 28 days prior to baseline assessment.
• Comorbidities limiting life expectancy to less than 12 months from the baseline assessment.
• Medical or psychiatric condition serious or active which might interfere with the treatment of study, assessment or protocol fulfillment.
• Positive test for HBsAg, HCV antibody, syphilis screening essays, or HIV antibody at screening.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (2)

Servicio de Neumología, Clínica Universidad de Navarra

Pamplona, Navarre, 31008 Pamplona, Spain

Location

Servicio de Neumología. Hospital Universitario de Salamanaca

Salamanca, Spain

Location

Related Publications (1)

• Campo A, Gonzalez-Ruiz JM, Andreu E, Alcaide AB, Ocon MM, De-Torres J, Pueyo J, Cordovilla R, Villaron E, Sanchez-Guijo F, Barrueco M, Nunez-Cordoba J, Prosper F, Zulueta JJ. Endobronchial autologous bone marrow-mesenchymal stromal cells in idiopathic pulmonary fibrosis: a phase I trial. ERJ Open Res. 2021 Jun 28;7(2):00773-2020. doi: 10.1183/23120541.00773-2020. eCollection 2021 Apr.

  PMID: 34195252 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 9, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

ES (2)